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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
22/07/2015
Funder:
Cancer Research UK
Sponsor:
Canadian Cancer Trials Group
Chief Investigator:
Mr John Tidy
Recruitment target:
100
EudraCT number:
N/A
Contact details:
ctc.SHAPE@ucl.ac.uk
Lay summary:
SHAPE
A randomised phase III trial comparing radical hysterectomy and pelvic node dissection vs simple hysterectomy and pelvic node dissection in patients with low-risk early-stage cervical cancer
Description
Design: SHAPE is a multi-centre, international, prospective, randomised phase III trial of radical hysterectomy and pelvic node dissection versus simple hysterectomy and pelvic node dissection in patients with previously untreated, low-risk cervical cancer.  It is an international trial led by the Canadian Cancer Trials Group and co-ordinated in the UK by the UCL CTC.
Treatment: Patients are randomised to receive one of the two treatments; the control arm will receive radical hysterectomy with pelvic node dissection and the experimental arm will receive simple hysterectomy with pelvic node dissection. Sentinel node mapping is optional in either arm. 
Key inclusion/exclusion criteria:
Inclusion: Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Patient classified as low-risk early stage cervical cancer (FIGO IA2 or IB1). Patients must be suitable candidates for surgery and have no desire to preserve fertility. Patients must be aged 18 or over and be able/willing to complete the Quality of Life and Health Economics questionnaires. 

Exclusion: Patients with FIGO IA1 disease. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin’s lymphoma or non-Hodgkin’s lymphoma curatively treated with no evidence of disease for >5 years. Evidence of lymph node metastasis on preoperative imaging or histology. Patients who had or will receive neoadjuvant chemotherapy. Patients who are pregnant. 

Duration of recruitment: 3.5 years.
Aim
To evaluate whether simple hysterectomy and pelvic node dissection is non-inferior to treatment with radical hysterectomy and pelvic node dissection in terms of pelvic relapse free survival. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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